Learning Small Bowel Capsule Endoscopy

May 30, 2022 updated by: Anders Bo Nielsen, Odense University Hospital
This project is a prospective study investigating the education of medical doctors in gastroenterology with no prior experience to evaluate small bowel capsule endoscopies with a diagnostic sensitivity >90%

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Region Of Southern Denmark
      • Odense, Region Of Southern Denmark, Denmark, 5000
        • Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Medical Doctors in medical gastroenterology or surgery with no prior experience in the evaluation of small bowel capsule endoscopies.

Description

Inclusion Criteria:

  • Medical Doctors in medical gastroenterology or surgery

Exclusion Criteria:

  • Prior experience with evaluation of small bowel capsule endoscopy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Medical doctors
Medical doctors with no prior experience in the evaluation of small bowel capsule endoscopy.
Other: Simulation training in small bowel capsule endoscopy
Training in the evaluation of small bowel capsule endoscopies including evaluation, diagnostic and treatment in different cases.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic sensitivity >90%
Time Frame: 1.5 year
Percentage of total number of correct diagnostic evaluated cases
1.5 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostics
Time Frame: 1.5 year
Percentage of correct diagnostic description
1.5 year
Clinical consequence
Time Frame: 1.5 year
Percentage of correct clinical consequence
1.5 year
Total time
Time Frame: 1.5 year
Total time use for all evaluated cases.
1.5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 29, 2018

Primary Completion (ACTUAL)

February 1, 2020

Study Completion (ACTUAL)

February 1, 2020

Study Registration Dates

First Submitted

December 2, 2019

First Submitted That Met QC Criteria

December 2, 2019

First Posted (ACTUAL)

December 4, 2019

Study Record Updates

Last Update Posted (ACTUAL)

June 1, 2022

Last Update Submitted That Met QC Criteria

May 30, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OP_736

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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